Gastrostomy involves the surgical creation of an opening (gastrostomy tract) through the abdominal wall of a patient into the stomach. A device sometimes referred to as a skin level device or “SLD” is used to line this opening for delivery of nutrition directly into the stomach. An SLD typically includes an internal bolster configured to be positioned inside the stomach, an external bolster configured to be positioned on the skin on the outside of the patient, and a tubular shaft connecting the two bolsters and lining the gastrostomy tract. An SLD of conventional design has a shaft length generally corresponding to the length of the gastrostomy tract of the patient. During feeding sessions a feed tube is attached to the external bolster of the SLD for delivery of nutrients to the stomach. A one-way valve prevents leakage or backflow of gastric contents.
To select a SLD for a patient, a measuring device is used after the gastrostomy tract is created to determine the gastrostomy tract length, and a SLD with a corresponding SLD shaft length is chosen.
A key drawback of conventional SLDs is the need for replacement if the length of the gastrostomy tract changes. For example, if the patient using the SLD gains weight, the length of the gastrostomy tract will increase and an SLD having a longer shaft length is needed. Neglecting to address this issue can result in Buried Bumper Syndrome (BBS), resulting in overgrowth of gastric mucosa over the internal bolster, and/or the internal bolster being forcibly drawn into the gastric wall. Complications arising from BBS can include gastrointestinal bleeding, perforation of the stomach, and even death. Conversely, if the patient loses weight, the length of the gastrostomy tract will decrease and a shorter SLD is required to prevent leakage of gastric contents.
In another example, gastrostomy formation usually leads to inflammation and swelling. A SLD installed at the time of gastrostomy formation will loosen as the inflammation and swelling subsides and the tract length decreases. A step-up ‘shim’ (e.g., U.S. Pat. No. 6,231,549) may be employed in such cases to effectively reduce the SLD shaft length, but this technique is only useful for a one-time, single-value adjustment and requires manual intervention. Additionally, shims are inoperable in the weight gain scenario described above. Other manual adjustment approaches involve the use of manually adjustable spring clips (e.g., U.S. Patent Application Pub. No. 2006/0052752) or replacing the SLD altogether.
There is a need, therefore, for an improved SLD that avoids the problems and inconveniences associated with conventional SLDs.